A Post-Market Clinical Evaluation of the ReUnion Reversible Fracture (RFX) System

Stopped early

Conditions studied: Arthroplasty, Hemiarthroplasty, Shoulder Pain

In brief

This investigation is a prospective, multi-center clinical investigation. It is anticipated that a total of one hundred (100) subjects will be enrolled at approximately 5-10 sites. The clinical investigation has been designed to follow the surgeon's standard of care for joint arthroplasty patients, which entails clinical evaluation on a regular ongoing basis, or as needed should the patient become symptomatic in the treated joint.

Key facts

Study ID

NCT04089371

Run by

Stryker Trauma and Extremities

People needed

10

Starts

2019-10-01

Expected to finish

2022-07-08

Last updated by the study team

2025-01-20

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is willing to sign the informed consent.
• Subject is willing and able to comply with postoperative scheduled clinical evaluations.
• Subject is male or non-pregnant female and 18 years or older at the time of surgery.
• When used with ReUnion Total Shoulder Arthroplasty (TSA)Humeral \& Glenoid components as a Hemiarthroplasty or Total Shoulder Replacement, subject has one or more of the following:
• Aseptic necrosis of humeral head;
• Painful, disabling joint disease of the shoulder resulting from degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis;
• Proximal humeral fracture and/or dislocation;
• Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results;
• Previous unsuccessful total shoulder replacement, resurfacing or other procedure
• When used with ReUnion RSA Humeral \& Glenoid Components as a primary, fracture or revision total shoulder replacement, subject's joint has gross rotator cuff deficiency, a functional deltoid muscle and is anatomically and structurally suited to receive the implant, and subject has one or more of the following:
• Painful, disabling joint disease of the shoulder resulting from degenerative arthritis or rheumatoid arthritis;
• Proximal humeral fracture
• Previously failed shoulder joint replacement

You may not qualify if…

• Subject has an active or suspected latent infection in or about the shoulder joint.
• Subject has mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure or complications in postoperative care.
• Subject has bone stock compromised by disease, infection or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
• Subject has anticipated activities which would impose high stresses on the prosthesis and its fixation.
• Subject is obese such that he/she produces a load on the prosthesis which can lead to failure of fixation of the device or to failure of the device itself.
• Subject has severe concomitant disease(s)which may significantly affect the clinical outcome.
• For Total Shoulder Arthroplasty and Hemiarthroplasty: Subject has absent, irreparable or non-functioning rotator cuff and other essential muscles

Where it is running

• Great Plains Orthopaedics — Peoria, Illinois, United States
• Steadman Hawkins — Greenville, South Carolina, United States
• Tennessee Orthopaedic Alliance — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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